Institute of Biochemistry German Sport University Cologne WADA-accredited Laboratory for Doping Analysis Accreditation ISO/IEC 17025:2005; D-PL-13340-01-00

Cologne, 11.08.2014

Documentation Package sample B 6050816

Federation: Code no.: Lab no:. Sample receipt: Adverse Analytical Finding:

ISC B 6050816 7397 B 21.05.2014 Recombinant Erythropoietin

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INSTITUT FÜR BIOCHEMIE, AM SPORTPARK MÜNGERSDORF 6, D50933 KÖLN

Documentation Package Page 1. 1.1 1.2 1.3

Documentation Cover page…………………………………......………………………….. 1 Laboratory statement……………………..………………………………. 2 Table of contents………………………………………………………….. 3

2. 2.1 2.2 2.3 2.4 2.5 2.6

2.7 2.8

Chain of Custody sample B 6050816 Summary of findings with guidance through the chain of custody…… Verification of sample identity…...…………………………………..…… Protocol for resealing………..…...…………………………………..…… List of laboratory staff involved in the test of sample B 6050816.……. Sample collection control form..…….……………………….…………... Documentation of shipping and receipt of intact sample, documentation linking sample identification number to laboratory identification number……………………………………..……….………. Urine integrity test B 6050816……………………………………………. B-sample bottle laboratory internal chain of custody (part 1 / part 2)..

3.

Sample B 6050816: Confirmation test data SAR-PAGE (11.1)

3.1

Brief confirmation test description, aliquot laboratory chain of

4 5 6 7 8

9 (and page 12) 10-11 12-13

custody documentation…………………………………………………… 14-15 3.2

Confirmation test results on sample B 6050816, rEPO references, uEPO reference and quality controls………………….…………..…….. 16-23

3.3

Certifying scientist review……..…………………………………………. 24

4.

Certified test reports

4.1.

Second opinion Laboratory Seibersdorf……....………………………... 25

4.2

Sample B 6050816 certified analytical report…………...………...…... 26

4.3

ADAMS report……………………………………………………………..

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INSTITUT FÜR BIOCHEMIE, AM SPORTPARK MÜNGERSDORF 6, D50933 KÖLN

Summary of findings with guidance through the chain of custody

Reception of A/B bottle 6050816

21.05.2014

Registration of A/B bottle 6050816

21.05.2014

Storage of A/B bottle 6050816 (frozen)

22.05.2014 / 21.05.2014

Confirmation SAR-PAGE (11.1*/ Gel 332) of B 6050816 Result: recombinant erythropoietin

07.07.2014

Analytical report of B 6050816

09.07.2014

Data transfer into ADAMS

10.07.2014

SOP: *) Detection of various erythropoiesis stimulating agents (ESAs) in human urine and blood by SDS- and SAR-PAGE respectivly and immunoblotting.

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INSTITUT FÜR BIOCHEMIE, AM SPORTPARK MÜNGERSDORF 6, D-50933 KÖLN

List of laboratory staff involved in the test Qualification Tasks

Name Blobel

Mike

Technician

Scr. 11, 11.1, 21, 24, 25

Geyer

Hans

Ph.D.

Deputy head of laboratory

Klose

Christiane

Scientific Associate

Office

Reihlen

Philipp

Scientific Associate

Scr. 21, 24 / Responsible for Scr. 11, 11.1, 25

Schänzer

Wilhelm

Ph.D. Professor

Head of laboratory

Schertel

Thomas

Scientific Associate

Sample reception and preanalysis procedure

Schmidt

Thomas

Student Assistant Sample reception and preanalysis procedure

Wick

Torsten

Scientific Associate

Initials

Sample reception and preanalysis procedure

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INSTITUT FÜR BIOCHEMIE, AM SPORTPARK MÜNGERSDORF 6, D50933 KÖLN

Urine integrity test

Densitymeter and pH-meter:

Lab. Code Dichte- und pH-Messeinheit

Manufacturer/Typ Densitymeter: PAAR (AU)/DMA38 pH: CONSORT C3010

further details PC controlled (DensiLab)

2.5 ml of each sample are pipeted into a tube, connected to the laboratory code number. Specific gravity and pH-value is measured automatically. The data are transferred into the LIMS.

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Institut für Biochemie, DSHS Köln

Analysen Werte

Datum: 07.07.14

EDatum AuftragNr 07.07.14 C8310058087

LaborNr B7397

phc: pH-Wert, sgb: Spez.Gewicht, phc4: pH-Wert 4, phc9: pH-Wert 9,

Blatt: 1 phc 6.35

sg sgb dib phc4 phc7 phc9 1.016 1.01

sg: Spez.Gewicht, dib: Dichte Biegeschwinger, g/ccm3 phc7: pH-Wert 7,

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Institut für Biochemie Institute of Biochemistry Akkreditierung nach ISO/IEC 17025:2005 (DAkkS-Reg.Nr.: PL-13340-01)

 

 

Sample bottle laboratory internal chain of custody – Sample A/B 6050816

Versender: TNT

Bote/Nr: 428439690

Absender: ISC

Ansprechpartner: May

Verband /Auftraggeber: ISC Probenart: OOC Probentyp: HU

Labor-Nr. A/B

Code-Nr A/B

TMC

Disziplin

Flaschensystem

Geschlecht

7397

6050816

576-038-14

Track

Berlinger

1

7397-B

B6050816

576-038-14

Track

Berlinger

1

Probenbewegung:  Datum  21.05.2014 09:08  21.05.2014 09:15  21.05.2014 13:34  21.05.2014 13:49  21.05.2014 13:55  22.05.2014 14.10  04.06.2014 08:25 

in Raum  R710  R702  R710  R702  R721a  R721a  R715 

Betreuer  T. Wick  T. Schertel  T. Schmidt  T. Schmidt  T. Schertel  M. Scharf  P. Reihlen 

Grund  Annahme A/B  Einlagerung nach Annahme A/B  vor Registrierung A/B  nach Registrierung A/B  B‐Probe einfrieren  A‐Probe einfrieren  Sicherung der Probenflaschen  A/B 6050816 Lagerung bei -20°C±4°C 

R 702 = Room 702: R 708 = Room 708: R 710 = Room 710:

Locked sample storage room (+ 4°C) in the secured area of the Institute of Biochemistry Office of Head of Laboratory in the secured area of the Institute of Biochemistry Laboratory room / sample registration in the secured area of the Institute of Biochemistry R 715 = Room 715: Locked sample storage container (-20°C  4°C) for suspicious samples and samples with adverse analytical finding(s) in the secured area of the Institute of Biochemistry R 721a = Room 721a: Locked sample storage room (-15°C  4°C) in the secured area of the Institute of Biochemistry

Dokument generiert aus Kennwort‐geschütztem LIMS des Institut für Biochemie; Dateneingabe und Zugriff nur durch  autorisierte Mitarbeiter nach personenbezogener Anmeldung.  DocPack Sample B6050816

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GASepo software (c) 2004-2007 Austrian Research Centers GmbH - ARC.

1

2

3

n. def.%

100,0%

3. ESA-Mix

α

n. def.%

0,0%

4. 7397-B

1

2

3

n. def.%

100,0%

5. ESA-Mix

GASepo Analysis Report

COLORLEGEND: EPOαβ DARBEPOETINα

α

n. def.%

n. def.%

1

100,0%

0,0%

1. pos Qc [Bi 2. pos Qc [B opoin] Urin RP] Urin

Session: Analysis 0332_SAR_8sec.tif 2014-07-09 Image File: 0332_SAR_8sec.tif Operator: Mike Blobel

09.07.2014 10:39

α

n. def.%

0,0%

6. neg Qc U rin

α

n. def.%

0,0%

7. NIBSC

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2.1.2

Laboratory: Manfred Donike Institut Date of Analysis: 09.07.2014 10:28

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α

α

Name

Comment 29,2

300,9

3269,17

13

Cent X Cent Y Cent Z Max X

Lane #1: pos Qc [Biopoin] Urin

GASepo Analysis Report

GASepo software (c) 2004-2007 Austrian Research Centers GmbH - ARC.

α

n. def.%

0,0%

1. pos Qc [Biopoin] Urin

Session: Analysis 0332_SAR_8sec.tif 2014-07-09 Image File: 0332_SAR_8sec.tif Operator: Mike Blobel

09.07.2014 10:39

304

Max Y

Volume Abs

100,0

2.1.2

Volume nMax

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10925,45 11301500,0

Max Z

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1

1

Name

Comment 27,6

282,9

7538,98

26

Cent X Cent Y Cent Z Max X

Lane #2: pos Qc [BRP] Urin

GASepo Analysis Report

GASepo software (c) 2004-2007 Austrian Research Centers GmbH - ARC.

1

n. def.%

100,0%

2. pos Qc [BRP] Urin

Session: Analysis 0332_SAR_8sec.tif 2014-07-09 Image File: 0332_SAR_8sec.tif Operator: Mike Blobel

09.07.2014 10:39

289

Max Y

Volume Abs

100,0

2.1.2

Volume nMax

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17077,30 21757490,0

Max Z

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1

1

30,2 30,7

2 1

291,7

223,7

42,0

5619,74

7464,28

692,80

49

51

47

Cent X Cent Y Cent Z Max X 34,2

Comment

3

Name

Lane #3: ESA-Mix

GASepo Analysis Report

GASepo software (c) 2004-2007 Austrian Research Centers GmbH - ARC.

2

3

2

3

n. def.%

100,0%

3. ESA-Mix

Session: Analysis 0332_SAR_8sec.tif 2014-07-09 Image File: 0332_SAR_8sec.tif Operator: Mike Blobel

09.07.2014 10:39

291

223

36

Max Y

783555,6

Volume Abs

13513,59

5355614,0

42,5

100,0

6,2

2.1.2

Volume nMax

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16028,83 12614640,0

1825,32

Max Z

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α

α

Name

Comment 36,0

296,6

16946,26

52

Cent X Cent Y Cent Z Max X

Lane #4: 7397-B

GASepo Analysis Report

GASepo software (c) 2004-2007 Austrian Research Centers GmbH - ARC.

α

n. def.%

0,0%

4. 7397-B

Session: Analysis 0332_SAR_8sec.tif 2014-07-09 Image File: 0332_SAR_8sec.tif Operator: Mike Blobel

09.07.2014 10:39

301

Max Y

Volume Abs

100,0

2.1.2

Volume nMax

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45212,65 47788450,0

Max Z

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1

1

1

32,1

32,8

2 291,9

224,8

36,5

5527,74

7028,65

1509,04

15

52

40

Cent X Cent Y Cent Z Max X 35,6

Comment

3

Name

Lane #5: ESA-Mix

GASepo Analysis Report

GASepo software (c) 2004-2007 Austrian Research Centers GmbH - ARC.

2

3

2

3

n. def.%

100,0%

5. ESA-Mix

Session: Analysis 0332_SAR_8sec.tif 2014-07-09 Image File: 0332_SAR_8sec.tif Operator: Mike Blobel

09.07.2014 10:39

292

227

35

Max Y

1139327,0

Volume Abs

12566,57

5229237,0

44,6

100,0

9,7

2.1.2

Volume nMax

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16283,26 11723780,0

4624,50

Max Z

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α

α

Name

Comment 25,4

308,2

4716,15

39

Cent X Cent Y Cent Z Max X

Lane #6: neg Qc Urin

GASepo Analysis Report

GASepo software (c) 2004-2007 Austrian Research Centers GmbH - ARC.

α

n. def.%

0,0%

6. neg Qc Urin

Session: Analysis 0332_SAR_8sec.tif 2014-07-09 Image File: 0332_SAR_8sec.tif Operator: Mike Blobel

09.07.2014 10:39

309

Max Y 9633,08

Max Z

7234579,0

Volume Abs

2.1.2

Report Page 8/ 10

100,0

Volume nMax

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α

α

Name

Comment 32,1

311,3

5047,33

49

Cent X Cent Y Cent Z Max X

Lane #7: NIBSC

GASepo Analysis Report

GASepo software (c) 2004-2007 Austrian Research Centers GmbH - ARC.

α

n. def.%

0,0%

7. NIBSC

Session: Analysis 0332_SAR_8sec.tif 2014-07-09 Image File: 0332_SAR_8sec.tif Operator: Mike Blobel

09.07.2014 10:39

311

Max Y 12102,65

Max Z

9907905,0

Volume Abs

2.1.2

Report Page 9/ 10

100,0

Volume nMax

Laboratory: Manfred Donike Institut Date of Analysis: 09.07.2014 10:28

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Prof. Wilhelm Schänzer Institut für Biochemie Deutsche Sporthochschule Köln Am Sportpark Müngersdorf 6 50933 Köln 2014/07/09

Re: Experts opinion on sample 7397-B Laboratory request by: Sample Code: Files submitted:

Cologne

Date of submission:

20140709

7397-B 0332_SAR_8sec.tif; Analysis 0332_SAR_8sec.tif 2014-07-09.ges.pdf, 7397 B Doku.pdf

Dear Prof. Schänzer, after reviewing the submitted files according to the lane description we conclude that the data from SAR-PAGE show a band shape normally not found in the urine samples containing solely endogenous EPO. The sample complies with the positivity criteria as described in the TD2013EPO. Due to the fact, that the sample does not show any sign of instability as shown by SARPAGE, a conclusion, that the sample contains recombinant erythropoietin is justified. Consequently the analysis of the B-sample confirms the result of the A-sample analysis. Yours sincerely,

Christian Reichel

Günter Gmeiner

-----------------------------------------------------------Dr. Christian Reichel Seibersdorf Labor GmbH Dopingkontroll-Labor A-2444 Seibersdorf Tel.: +43/0 50550 3572 Fax: +43/0 50550 3566 E-mail: [email protected] Web: http://www.antidoping.at

-----------------------------------------------------------Dr. Günter Gmeiner Seibersdorf Labor GmbH Dopingkontroll-Labor A-2444 Seibersdorf Tel.: +43/0 50550 3539 Fax: +43/0 50550 3566 E-mail: guenter.gmeiner@ seibersdorf-laboratories.at Web: http://www.antidoping.at

------------------------------------------------------------

------------------------------------------------------------

Seibersdorf Labor GmbH | 2444 Seibersdorf, Austria | Tel.: +43 (0) 50550-2500 | Fax: +43 (0) 50550-2502 | Mail: [email protected] www.seibersdorf-laboratories.at | Landesgericht Wiener Neustadt | FN 319187v | DVR: 4000728 | UID: ATU64767504 | Steuernummer: 192/6571 | Zertifiziert nach ISO 9001:2000 Bankverbindung: Erste Bank der Österreichischen Sparkassen AG | BLZ 20111 | Konto Nr. 291-140-380/00 | IBAN AT112011129114038000 | BIC GIBAATWW

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Page 1 / 1 Laboratory for Doping Analysis - German Sports University Cologne German Sports University Cologne Am Sportpark Müngersdorf 6 Köln GERMANY 50933 Tel: +49 221 498 24 920 Fax: +49 221 497 32 36

Test Report/ Rapport dé Essai CONFIDENTIAL / CONFIDENTIEL

SCA:

TA :

ISC Una May Top Floor, Block A West End Office Park Blanchardstown Dublin IRELAND 15

ISC Una May Top Floor, Block A West End Office Park Blanchardstown Dublin IRELAND 15

Test result / Résultat du contrôle

: AAF - Adverse Analytical Finding

Sample Code / Code d'échantillon

: 6050816

Sample A/B / Échantillon A/B

: B

Specific Gravity / Gravité spécifique

: 1.015

pH

: N/A

Lab Reference # / No de référence de labo : N/A Test Mission Code / Code de mission

: 576-038-14

Type of Test / Nature du contrôle

: Out competition

Sport-Discipline / Sport-Discipline

: Athletics - Track

Collection Date / Date du prélèvement

: N/A

Collection Site / Lieu du prélèvement

: N/A

Date of Receipt / Date de réception

: 21-May-2014

Sample Type / Nature de l'échantillon

: Urine

Gender / Sexe

: M

Additional analysis(es) performed / Analyse additionelle: EPO (including recombinant EPO’s and analogues) Analysis Details / Explanation / Opinion Détails de l'analyse / Explication / Opinion: N/A The sample was analysed using Laboratory test method(s)/ L’échantillon a été examiné selon les méthodes d’analyse du laboratoire: N/A Results / Résultats: The analysis of the sample identified above has shown the presence of / L'analyse de l'échantillon mentionné ci-dessus par les méthodes du laboratoire a révélè la présence de: AAF - Adverse Analytical Finding

- S2. Peptide Hormones, Growth Factors and Related Substances/erythropoietin (EPO).

Details concerning Finding: N/A

Cc: WADA-AMA, ISC, IAAF Lab results status / Etat du résultat de laboratoire: Submitted

Modified on / Mis à jour le: 10-Jul-2014

Submitted by / Soumis par: Klose, Christiane

Printed on / Imprimé le: 11-Aug-2014

Submitted on / Soumis le: 10-Jul-2014

Printed by / Imprimé par : Klose, Christiane Adams Lab Form Rev 3.0.2 01/2014

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